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Effect of Clamshell Exercise on Lumbopelvic Stability and Low Back Pain in Post Partum Women

Primary Purpose

Lumbosacral Instability, Low Back Pain Post Partum

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Abdominal bracing
clamshell exercise
Sponsored by
Eman Mahmoud Mahmoud El-sayed Ellily
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbosacral Instability focused on measuring clamshell exercise, lumbopelvic instability, low back pain, post partum

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Post-partum females complaining of LBP and lumber instability Their age will be ranged from 25-35 years. Their BMI will be ranged from 25-30 kg/m2 Exclusion Criteria: Spinal deformity. Lower limb deformity. Osteosarcoma Mental disorders. 5-25>BMI>30 6-Performing any physical exercise at the time of the study. 7-Bad general Health

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    control group

    study group

    Arm Description

    Abdominal bracing

    Abdominal bracing and clamshell exercise

    Outcomes

    Primary Outcome Measures

    Change in the degree of lumbopelvic instability
    Change in the degree of lumbopelvic instability will be measured by specific tests(The dip test, the runner pose test and the single leg squat test) and the pateint performance will be graded as poor or good
    lumbopelvic range of motion
    Degree of lumbopelvic range of motion will be measured by goniometer

    Secondary Outcome Measures

    severity of pain intensity
    change in low back pain intensity will be measured using visual analogue scale(VAS) low back pain intensity
    the degree of function disability
    the change in the degree of function disability will be measured by Oswestry disability index (ODI)

    Full Information

    First Posted
    April 6, 2023
    Last Updated
    May 7, 2023
    Sponsor
    Eman Mahmoud Mahmoud El-sayed Ellily
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05848479
    Brief Title
    Effect of Clamshell Exercise on Lumbopelvic Stability and Low Back Pain in Post Partum Women
    Official Title
    Effect of Clamshell Exercise on Lumbopelvic Stability and Low Back Pain in Post Partum Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 26, 2023 (Anticipated)
    Primary Completion Date
    July 26, 2023 (Anticipated)
    Study Completion Date
    July 26, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Eman Mahmoud Mahmoud El-sayed Ellily

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will be conducted on 44 females with postpartum LBP & pelvic instability, selected from Dar of women hospital in port said to investigate effect of clamshell exercise on lumbo-pelvic stability and low back pain in postpartum women.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbosacral Instability, Low Back Pain Post Partum
    Keywords
    clamshell exercise, lumbopelvic instability, low back pain, post partum

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    Abdominal bracing
    Arm Title
    study group
    Arm Type
    Active Comparator
    Arm Description
    Abdominal bracing and clamshell exercise
    Intervention Type
    Other
    Intervention Name(s)
    Abdominal bracing
    Intervention Description
    they will perform 3 times/week of static abdominal contraction for six weeks.
    Intervention Type
    Other
    Intervention Name(s)
    clamshell exercise
    Intervention Description
    Each women will be positioned in side lying on the floor, with the pelvis and the spine in neutral position, the hips will bent at 45° and the knees flexed to 90°. She will abduct the top knee as far as possible, while keeping the heels together, then return to the starting position , the position will be maintained for 5 seconds in an abduction state, and repeated 10 times, with rest for 1 minute to minimize muscle fatigue,they will perform 3 times/week fo 6 weeks
    Primary Outcome Measure Information:
    Title
    Change in the degree of lumbopelvic instability
    Description
    Change in the degree of lumbopelvic instability will be measured by specific tests(The dip test, the runner pose test and the single leg squat test) and the pateint performance will be graded as poor or good
    Time Frame
    change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions
    Title
    lumbopelvic range of motion
    Description
    Degree of lumbopelvic range of motion will be measured by goniometer
    Time Frame
    change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions
    Secondary Outcome Measure Information:
    Title
    severity of pain intensity
    Description
    change in low back pain intensity will be measured using visual analogue scale(VAS) low back pain intensity
    Time Frame
    change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions
    Title
    the degree of function disability
    Description
    the change in the degree of function disability will be measured by Oswestry disability index (ODI)
    Time Frame
    change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Post-partum females complaining of LBP and lumber instability Their age will be ranged from 25-35 years. Their BMI will be ranged from 25-30 kg/m2 Exclusion Criteria: Spinal deformity. Lower limb deformity. Osteosarcoma Mental disorders. 5-25>BMI>30 6-Performing any physical exercise at the time of the study. 7-Bad general Health
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman M Mahmoud
    Phone
    + 2 1091403074
    Email
    amira.mahmoud2021@outlook.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    mahitab Y Ibrahim
    Phone
    + 2 1222606996
    Email
    mahitab.yosri@pt.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Clamshell Exercise on Lumbopelvic Stability and Low Back Pain in Post Partum Women

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